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October 21, 2016 10:30 AM

Keeping a Safe, Effective Product on the Store Shelves

By Richard Sedlak and Paul DeLeo

The Food and Drug Administration (FDA) may be on the brink of banning safe and effective products, essentially eliminating consumer choice for millions of Americans.

Every day, antibacterial soaps are used in homes, offices, schools, child care centers and many other commercial settings. Yet a recent announcement by FDA cast an unrealistically dark picture of this category of products that have been on the shelves for decades.

Specifically, FDA issued a final rule governing particular active ingredients that can be used in consumer antibacterial soaps and washes.

The agency’s public statements summarizing that rule could sow consumer confusion about the amount of scientific data and research manufacturers have submitted over the years on product safety and effectiveness. Further, it can undermine what researchers are currently doing to answer new questions that have been identified by FDA.

Of the 19 antibacterial ingredients FDA ordered removed from the antibacterial soap marketplace during the next year, 17 of them hadn’t been supported by manufacturers or used in mass market products in decades.

The other two have been or are being replaced by companies and are likewise not supported in work moving forward.

A little perspective here is warranted. The agency has had over 40 years to decide on the safety and efficacy of the products and their ingredients. Proposed regulations governing antibacterial soaps and ingredients have been sitting at FDA since 1974.

As the agency updated those tentative rules over time, antibacterial soap and ingredient manufacturers provided thousands of pages of data supporting the safety and efficacy of their products, showing that they reduce harmful germs on the skin that can make people sick.

Along the way, FDA essentially moved the regulatory goalposts for manufacturers, requiring that the ingredients in consumer antibacterial soaps not just kill germs but reduce infectious disease. They called for clinical trials for these over-the-counter products so as to demonstrate their effectiveness. Though unprecedented, the industry is working with FDA to develop and carry out these trials.

What’s most unfortunate about FDA’s recent activity was the highly charged language that claimed using antibacterial soaps "may do more harm than good over the long-term." This ignores the agency’s own assessment of the information needed to address emerging science and the lack of any evidence that harm is actually occurring.

Further, the agency’s rule specifies new testing requirements, including some tests never performed for these types of products. When carried out, these tests would resolve uncertainties on the safety and efficacy of specific active ingredients the industry has agreed to support through a major testing program.

It seems like FDA has pre-determined an outcome before all the data they’ve requested has even been reviewed by the agency.

If these products were actually unsafe, companies would take them off the market.

Manufacturers stand behind the product science, research and data submitted over several decades to FDA.

Based on the newest understanding of the science and how the products are used, the industry was asked to undertake new studies.

The American Cleaning Institute just laid out a detailed work plan on additional safety and efficacy data for the three major ingredients used in consumer antibacterial soaps that aligns with FDA’s requests.

Additional data will be submitted for other ingredients used in healthcare antiseptic products, consumer hand sanitizers, and food handler antiseptics that are covered under upcoming regulations.

It is important for the American public to know that industry is complying with the FDA data requests, as laid out by FDA itself. It is an agency-defined road map to certainty about the safety and efficacy. The formal rulemaking is clear on this.

FDA statements denigrating antibacterial soaps inappropriately prejudice where we will be when we get to the end of the road that they themselves designed. Let’s hope this rhetoric does not stand in the way of science-based decision-making on these safe and effective products.


Richard Sedlak and Paul DeLeo are, respectively, executive vice president, technical & international affairs, and associate vice president, environmental safety, at the American Cleaning Institute, the trade association for the cleaning products industry.